最小化用于收集 存储和分析生物材料用于法医目的的产品中人类DNA污染的风险 - 要求

[中文适用范围]： 本国际标准规定了用于法医DNA分析目的的生物材料收集、储存和分析的产品的制造要求，但不包括后扩增分析中使用的消耗品和试剂。 本国际标准涵盖的消耗品和试剂包括证据采集（采样套件）使用的棉签、容器和包装，以及用于DNA样本分析的产品，如试管和其他塑料制品、一次性实验室外套、手套和其他消耗品。 本国际标准适用于不需要清洁以继续使用的产品的生产。本国际标准不涵盖技术产品规范（即产品设计）。本国际标准不包括微生物检测。 [外文原描述]： ISO 18385:2016 specifies requirements for the production of products used in the collection, storage, and analysis of biological material for forensic DNA purposes, but not those consumables and reagents used in post-amplification analysis. The consumables and reagents covered by this International Standard include those used for evidence collection (sampling kits), such as swabs, containers, and packaging, and also products used in the analysis of DNA samples, such as tubes and other plasticware, disposable laboratory coats, gloves, and other consumables. ISO 18385:2016 applies to the production of consumables and reagents which do not require cleaning for continued use. This International Standard does not cover technical product specifications (i.e. product design). ISO 18385:2016 excludes microbiological testing. ISO 18385:2016 specifies a requirement for manufacturers to minimize the risk of occurrence of detectable human nuclear DNA contamination in products used by the global forensic community.